Effective data management services facilitate efficient access,
processing, summarization, and dissemination of data and information.
At PMI, our data management services incorporate leading-edge
technology, 21 CFR Part 11 compliant systems, and experienced
clinical data management personnel to support both electronic
clinical data capture (EDC) and traditional Case Report Form
(CRF) double data-entry applications.
Our data management services are scalable to your needs and
emphasize well-organized, appropriately documented, accurate
and timely processing of your clinical data. Service areas
- Case Report Form (CRF) Design. Using
the study protocol, PMI’s Data Management Team prepares
and formats data collection forms indicating study data
fields to be collected and, where appropriate, allowable
responses for each field. Consideration is given to design
the CRFs in a user-friendly manner in order to minimize
entry errors, and study CRFs are formally reviewed by the
client prior to implementation.
- Clinical Data Management Plan. Using
the approved study CRFs, PMI develops detailed database
design specifications (DDS) for each client’s clinical
study database. Each DDS includes the form name, event name,
event structure, data field definitions, code-list and automated
edit checks. Based on the DDS, PMI team members prepare
the written data management plan, which includes CRFs, annotated
CRF, Group and User Set-Up Request Forms (for EDC study),
Risk Analysis assessment, Database Development Checklist,
Database Validation Plan, User Acceptance Test Plan, Data
Processing Guideline, In-House CRF Review Guideline, Data
Cleaning Guideline, Validation Report, User Acceptance Test
Report and Database Lock Check List. Data management plans
are formally reviewed by PMI and our clients at least bi-annually
and maintained using version control.
- Clinical Database Development. PMI’s
clinical databases are based on a Microsoft SQL-based platform.
Study-specific data entry screens, back-end tables, and
automated edit checks are programmed and validated in accordance
with the data management plan and 21 CFR part 11 requirements
- Clinical Data Entry, Data Processing, CRF Review,
Query Resolution. With PMI’s EDC system,
study data is entered via a secure Internet connection by
the study coordinator. Pre-programmed automated edit checks
are utilized to provide controls for data entry accuracy.
During site monitoring visits, data entry accuracy is also
confirmed by the visiting clinical research associate.
With PMI’s paper CRF system, completed CRFs, reviewed
and collected in conjunction with monitoring site visits,
are forwarded to PMI where they are logged and entered
into the database. Double data entry is performed by two
different data entry coordinators, and discrepancies are
adjudicated prior to finalization of entries. Data entry
personal are trained on the specific data processing guidelines,
and pre-programmed automated edit checks are utilized
to provide controls for data entry accuracy.
Meanwhile, PMI's EDC paper double entry functionality
provides flexibility to sponsors who prefer a hybrid method
of data collection.
Clinical Data Review & Query Resolution Data inconsistencies
that are not detected by automated edit checks are reviewed
per the In-House CRF Review Guideline. Using either paper
or electronic DCFs, additional queries may be generated
and transmitted to the study site.
PMI’s clinical database allows for tracking of CRFs
received by site and by subject. Additionally, each DCF
generated and its associated resolution status is tracked.
- Data Dictionary Processing. PMI provides
data coding services for adverse events, medications, and
medical history. Typically using MedDRA and WHO DRUG, coding
listings can be provided regularly for sponsor review.
- Data Imports. Written data import protocols
are co-developed with the central lab or reading center
and submitted to the sponsor for approval.
- Data Exports. Using PMI’s clinical
study management, data can be easily exported into a number
of formats including Excel spreadsheets, SAS datasets, ACCESS
tables and ASCII files.
- Data Quality Assurance. Typical data
quality assurance procedures include generation and review
of data inconsistency listings, confirmation of randomization
schedules, data entry versus source data and resolution
of data queries. Additionally, ad hoc data reports are developed
to provide study data analysis and metrics to clients, as
required, on an ongoing basis throughout the study conduct.
- Database Lock and Data Transfer. Upon
successful completion of necessary data quality assurance
procedures and a data lock checklist, PMI locks the clinical
study database and the data is transferred to the designated
biostatistician for analysis.
- Database Maintenance and Archival. PMI
maintains clinical databases for the duration of the project,
and typically through completion of the final clinical study
report. Subsequently, clinical study data is transferred
to our client in their designated format and archived as
specified in the project agreement.
- Security Procedures. Clinical data security
is enforced via use of a single user/password sign-on for
qualified, registered database users. Specific access roles
are granted as appropriate, and user passwords are changed
at specified intervals. Audit trails of server and record
access provide comprehensive tracking of modifications made
to data or programming files.
PMI’s systems are configured to facilitate rapid restoration
of data in the unfortunate event of server failure. Clinical
data and programming files are stored on servers located in
a secure, environmentally controlled area within PMI’s
corporate office in Costa Mesa, CA, and backed up daily at
an off-site hosting facility, which uses standard best practices
with respect to data security.